Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction

The Washington University

Status: Completed

Conditions: Environmental Enteric Dysfunction

Treatments: Dietary Supplement: Lysozyme; Dietary Supplement: Lactoferrin; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02925026

Lactoferrin-Lysozyme

Details and patient eligibility

About

Randomized, double-blind, placebo controlled trial of daily lactoferrin and lysozyme supplementation in improving environmental enteric dysfunction in Malawian children

Enrollment: 235 patients

Sex: All

Ages: 12 to 35 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• children aged 12-35 months
• youngest eligible child in each household

Exclusion criteria

• severe or moderate acute malnutrition
• severe chronic illness
• children unable to drink 20 mL of dual sugar solution
• children in need of acute medical treatment for illness or injury at time of enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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235 participants in 2 patient groups, including a placebo group

Lactoferrin+Lysozyme

Experimental group

Description:

lactoferrin and lysozyme in rice flour

Treatment:

Dietary Supplement: Lactoferrin

Dietary Supplement: Lysozyme

Placebo

Placebo Comparator group

Description:

rice flour

Treatment:

Dietary Supplement: Placebo